Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Oct 2023
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Carrie A Hughes, Nicholas L Hunt
6 Oct 2023
21 CFR 211.192
Written record of investigation incomplete
Cited by Carrie A Hughes, Nicholas L Hunt
6 Oct 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Carrie A Hughes, Nicholas L Hunt
6 Oct 2023
21 CFR 211.42(c)(10)(vi)
Equipment to control conditions
Cited by Carrie A Hughes, Nicholas L Hunt
Inspected site
RPROIS Phoenix IncPhoenix, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere